Augmenting Kinesthetic Feedback to Improve Hemiparetic Arm Control After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Root Mean Square Kinematic Error
研究概览
简要总结
Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the arm. Thirty subjects will be recruited to a single site to evaluate the ability of supplemental kinesthetic feedback (a form of vibrotactile stimulation) to improve motor function. Participants will be tested in performing reaching movements as well as more functional tasks such as simulated drinking from a glass
详细描述
This study has two distinct aims to be addressed in a longitudinal study spanning 24 days.
Aim 1 tests the hypothesis that stroke survivors can improve motor control of their contralesional arm through extended training with supplemental kinesthetic feedback applied to the non-moving arm and hand.
Aim 2 tests the hypothesis that extended training with supplemental kinesthetic feedback can lead to new skills that generalize to untrained reach-to-grasp actions like reaching for a water glass or a book on a shelf.
Day 1: Participants complete baseline tests of cognitive performance over several domains, including psychomotor speed (e.g., Symbol Digit Modalities Test; Digit Copy Test), memory (Rey Auditory Verbal Learning Test; Rey Osterrieth Complex Figure Test), cognitive flexibility/attention shifting (Trail-Making Test B; Wisconsin Card Sort Test), spatial processing (Rey Osterrieth Complex Figure copy test), and action selection/inhibition. (the go, no-go, and stop signal tests).
Day 2: Participants complete baseline tests of sensorimotor impairment and function. Tests of sensorimotor impairment include the upper extremity Fugl-Meyer Assessment for the contralesional arm, two-point discrimination, vibration sensation using a 128 Hz tuning fork, and a robotic test of proprioception in both arms. Motor function in the contralesional arm will be assessed using the Jamar grip strength assessment and the Wolf Motor Function Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke survivors who can perform our stabilization and grip modulation tasks and who
- •had a single ischemic or hemorrhagic stroke of the middle cerebral artery (MCA) in the chronic state of recovery (> 6 months post-stroke).
- •ability to give informed consent and be able to follow two-stage instructions.
- •mild-to-moderate motor impairment as assessed using the upper extremity (UE) portion of the Fugl-Meyer Motor Assessment (FM); i.e., UE-FM score between 28 and 50 (inclusive) out of a possible
- •proprioceptive deficit at the elbow in the more involved (contralesional) arm.
- •preserved tactile sensation in either the ipsilesional arm and/or thigh.
- •a minimal active wrist extension of 5°.
排除标准
- •Inability of subjects to give informed consent or follow two-stage instructions.
- •subjects with a bleeding disorder.
- •subjects with fixed contractures or a history of tendon transfer in the involved limb.
- •subjects with a diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any disease that might interfere with neuromuscular function.
- •subjects who are currently using or under the influence of aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function.
- •subjects with a history of epilepsy.
- •history of other psychiatric co-morbidities (e.g. schizophrenia).
- •malignant or benign intra-axial neoplasms.
- •concurrent illness limiting the capacity to conform to study requirements.
- •Cardiac pacemaker, cardiac arrhythmia or history of significant cardiovascular or respiratory compromise.
- •subjects with profound atrophy or excessive weakness of muscles in the target area(s) of testing.
- •subjects with a systemic infection.
结局指标
主要结局
Root Mean Square Kinematic Error
时间窗: across experimental sessions spanning a typical time frame of 4 to 6 weeks
orthogonal distance between target and hand position during reaching and stabilizing
次要结局
未报告次要终点